Durvalumab + Chemotherapy for Mesothelioma
(DREAM3R Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding durvalumab, an immunotherapy, to standard chemotherapy can benefit people with pleural mesothelioma, a cancer affecting the lung lining. The study aims to determine if this combination improves overall survival compared to other standard treatments or a different immunotherapy combo. It seeks participants with pleural mesothelioma that cannot be surgically removed. Those diagnosed with this condition and meeting the criteria might be suitable for the trial. As a Phase 3 trial, it represents the final step before FDA approval, offering access to potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them at least 28 days before starting the trial treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining durvalumab with chemotherapy is generally safe for people with certain cancers, such as mesothelioma. Studies have found that this combination is usually well-tolerated, with side effects similar to standard chemotherapy.
Other studies have found the combination of ipilimumab and nivolumab to be mostly safe for people with mesothelioma. Some patients lived longer, although results can vary.
Both treatment options have undergone testing in many patients, demonstrating general safety, though individual experiences may differ. Clinical trial participants receive close monitoring to manage any potential side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Durvalumab with chemotherapy for mesothelioma because it introduces an innovative approach to treatment by leveraging the power of immunotherapy. Durvalumab is an immune checkpoint inhibitor that works by unleashing the immune system to attack cancer cells more effectively, a departure from traditional chemotherapy that directly targets and kills cancer cells. This combination aims to enhance the body's natural defenses, potentially leading to more durable responses and improved survival rates compared to conventional treatments alone. Additionally, the use of Ipilimumab and Nivolumab, both of which are also immune checkpoint inhibitors, presents an alternative approach by combining two immunotherapies to potentially provide a robust defense against cancer progression.
What evidence suggests that this trial's treatments could be effective for pleural mesothelioma?
Research has shown that combining durvalumab with chemotherapy, which participants in this trial may receive, may help treat advanced pleural mesothelioma. Studies have found that this combination can extend patients' lives and delay disease progression. More patients also experienced tumor shrinkage with this treatment.
For another treatment arm in this trial, the combination of ipilimumab and nivolumab, research indicates that some patients lived about 15.5 months on average. About one-third of these patients experienced a significant reduction in tumor size. Both treatments offer potential benefits for those facing this challenging condition.23467Who Is on the Research Team?
Patrick Forde, MD
Principal Investigator
Johns Hopkins University
Anna Nowak, MD
Principal Investigator
Faculty of Health and Medical Sciences University of Western Australia
Are You a Good Fit for This Trial?
Adults over 18 with epithelioid pleural mesothelioma that can't be removed by surgery. They should have a good performance status, weigh more than 30 kg, and have acceptable blood test results. Women must not be pregnant and use contraception; men also need to follow certain contraceptive guidelines.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive durvalumab with standard chemotherapy or physician's choice of treatment for 4 to 6 cycles
Maintenance
Participants in the experimental arm receive durvalumab every 4 weeks until disease progression, unacceptable toxicity, or withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
- Ipilimumab and Nivolumab
- Standard Chemotherapy
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
PrECOG, LLC.
Lead Sponsor
Thoracic Oncology Group Australasia (TOGA)
Collaborator
University of Sydney
Collaborator
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology